The present invention is directed to medical and laboratory fluid specimen collecting and testing apparatus, and more specifically to an apparatus for detecting the presence of specific antigens in biological fluids.
It is generally necessary in diagnosing and testing for many diseases to collect biological fluids from a patient, e.g., sputum, blood, pleural, cavity and peritoneal cavity fluids for analysis. It is important during the collection handling of biological fluid specimens that the potential of specimen contamination and the spread of any infection from the specimen be minimized. In addition there is also the potential for specimen damage during the collection process as well as the potential for destruction of certain components of the specimen because the testing apparatus does not screen fluids or causes mixing of different fluid components which will negate the test results or result in false data being obtained when the specimen is tested.
In the health-care industry, diagnostic testing of blood has become routine, with physicians expecting and demanding a wide variety of specialized tests on patients' samples to support their diagnoses. To satisfy this ever increasing demand for analytical data from blood samples, sophisticated chemical analyzers have been developed over the past 20 years to perform a multiplicity of physical and chemical tests on specially prepared patients' samples. Regardless of the target analyte, sample volume requirements have been reduced substantially, to 100 uL or less for some tests. Whether the objective is a simple glucose assay, a leukocyte count, or a screening for a particular analyte, the potential risk of specimen contamination and the spread of any infection from the specimen after its collection remains unknown to the health-care worker. In most recent years this factor alone had contributed to the spread of several cases of highly infectious viral diseases such as AIDs and Hepatitis which could have been prevented if the samples were identified and treated accordingly.
There currently exists a need to collect and test biological fluids for the presence of diseases such as cancer or the presence of foreign bodies such as drugs which can be quickly and easily accomplished through visual quantitative testing. A new technology, along with the methodologies for implementation, to fully integrate the steps involved in the collection and processing of blood for diagnostic analysis is needed to: minimize the time required to obtain a clinically relevant answer regarding the patient's health; minimize the health risk associated with handling patients' samples; ensure positive patient identification for the samples and be a user-friendly and transparent to the user. cl Theory and Design of Immunoassays
The family of immunoassays works upon the single principal that is the specific recognition of an antigen by an antibody. The specific antigen detection and quantification requires an antibody which recognizes the uniqueness of an antigen. One unique binding site serves as an identifying marker for that protein. Thus detection can be direct where the antigen-specific antibody is purified, labelled and used to bind directly to the antigen or indirect where the antigen-specific antibody is unlabelled and need not be purified. In indirect detection the binding to the antigen is detected by a secondary reagent such as labelled anti-immunoblobulin antibodies or labelled protein A. A variation that uses aspects of both the direct and indirect methods modifies the primary antibody by coupling to it a small chemical group such as biotin and dinitrophenol (DNP) so that the modified primary antibody can then be detected by labelled reagents such as a biotin binding protein or hapten-specific antibodies such as antiDNP antibodies.